A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction

December 30, 2008 updated by: Embera NeuroTherapeutics, Inc.

A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Two Dose Combinations of Metyrapone and Oxazepam in the Treatment of Cocaine Addiction

Subjects will be randomly assigned to receive either one of the two potential dose combinations of the study medications or placebo over 6 weeks. The study will include twice weekly visits to the research clinic for laboratory studies, safety assessments and urine drug screens. Subjects will also be questioned regarding drug craving and mood symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Department of Psychiatry, Psychopharmacology Research Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, 18 - 50 years of age
  • Requests treatment for cocaine addiction
  • Meets the DSM-IV criteria for cocaine dependency
  • Able to provide written informed consent and comply with the study
  • Females of childbearing potential must have a negative pregnancy test and must be using adequate birth control during the study
  • Test positive for cocaine on a urinary drug screen
  • Healthy and medically stable in the opinion of the Principal Investigator

Exclusion Criteria:

  • Liver enzymes greater than two times normal
  • Any history of hepatitis
  • History of disorders requiring chronic treatment with steroids
  • Significantly abnormal ECG
  • Any prominent DSM-IV axis I disorders other than cocaine dependence
  • Any subject who presents as a danger to self or others in the opinion of the Principal Investigator
  • Concomitant use of methamphetamine as determined by self-reporting and verified by measurement of methamphetamine in urinary drug screen
  • Alcohol consumption greater than 4 drinks per day (1 Drink = 12 oz beer; 5 oz wine; 1.5 oz shot of liquor)
  • Any clinically significant laboratory test abnormalities
  • Use of any concomitant medication during the study that would interfere with study medications
  • Serum cortisol less than 3 µg/dl at any time before or during study
  • Treatment with an investigational product within 30 days prior to study enrollment
  • Currently seeking other forms of professional addiction treatment
  • Known allergic reaction to oxazepam or metyrapone
  • Lactose intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Drug: Placebo
Twice daily
Active Comparator: 1
Lower dose combination of metyrapone with oxazepam
Drug: Metyrapone
Twice daily
Other Names:
  • Metopirone
Drug: Oxazepam
Twice Daily
Other Names:
  • Serax
Active Comparator: 2
Higher dose combination of metyrapone with oxazepam
Drug: Metyrapone
Twice daily
Other Names:
  • Metopirone
Drug: Oxazepam
Twice Daily
Other Names:
  • Serax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology
Time Frame: 6 weeks
6 weeks
Improvement in anxiety and depression symptoms
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Embera NeuroTherapeutics, Inc.

Investigators

  • Principal Investigator: Anita S Kablinger, MD, LSU Health Sciences Center - Shreveport

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

December 3, 2007

First Submitted That Met QC Criteria

December 3, 2007

First Posted (Estimate)

December 5, 2007

Study Record Updates

Last Update Posted (Estimate)

December 31, 2008

Last Update Submitted That Met QC Criteria

December 30, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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